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Surgery for Vocal Cord Paralysis

Primary Purpose

Unilateral Vocal Cord Paralysis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vocal fold medialization
vocal fold reinnervation
Sponsored by
National Institute on Deafness and Other Communication Disorders (NIDCD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Vocal Cord Paralysis focused on measuring unilateral vocal fold paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria clinical diagnosis of unilateral vocal fold paralysis older than 18 years of age intact ansa cervicalis and recurrent laryngeal nerves life expectancy of greater than 2 years onset of the vocal fold paralysis within 2 years of the time of surgery no gelfoam injection for at least 4 months prior to initial data collection able to give informed consent willing and able to return for 6 and 12 month data collection sessions able and willing to perform questionnaire (by mail) 18 months after surgery Exclusion criteria abnormal non-paralyzed fold other disorders affecting the larynx (voice box), such as multiple sclerosis, myasthenia gravis, spasmodic dysphonia, or essential voice tremor prior surgery to either vocal fold previous or planned irradiation of the voicebox

Sites / Locations

  • University of Alabama-Birmingham
  • UC-Irvine Medical Center
  • George Washington University
  • University of Minnesota
  • Washington University
  • University of Cincinnati
  • Cleveland Clinic
  • University of Oklahoma
  • Thomas Jefferson University
  • University of Utah
  • University of Wisconsin
  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 9, 2003
Last Updated
April 21, 2006
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00064571
Brief Title
Surgery for Vocal Cord Paralysis
Official Title
Medialization Vs Reinnervation for Vocal Cord Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Terminated
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

5. Study Description

Brief Summary
Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy". Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has some potential advantages over the medialization operation also requires several months for final results to be gained. The goal of this multicenter, randomized clinical trial is to see which of the two surgical treatments produces a better outcome. In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist. Information collected for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings, movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an outcomes questionnaire.
Detailed Description
Unilateral vocal fold paralysis (UVFP) is caused by injury to the recurrent laryngeal nerve. Patients with UVFP may have significant impairment of vocal fold function, including a breathy paralytic dysphonia. There are several available approaches for the treatment of this condition. Vocal fold medialization is currently used by most otolaryngologists and is probably the standard of care for treating UVFP. An alternative approach is laryngeal reinnervation, which has a number of potential advantages over medialization but which requires several months before a final result is achieved. The primary goal of this multicenter, randomized clinical trial is to determine which approach produces a better outcome. Patients with UVFP meeting all inclusion criteria and released from therapy by a speech-language pathologist will be randomized into either the medialization arm or the reinnervation arm. The data collection protocol consists of voice recordings, aerodynamic measurements, electroglottography, videostroboscopy, and a clinical outcomes questionnaire collected pre-treatment and at 6 and 12 months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Vocal Cord Paralysis
Keywords
unilateral vocal fold paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
vocal fold medialization
Intervention Type
Procedure
Intervention Name(s)
vocal fold reinnervation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria clinical diagnosis of unilateral vocal fold paralysis older than 18 years of age intact ansa cervicalis and recurrent laryngeal nerves life expectancy of greater than 2 years onset of the vocal fold paralysis within 2 years of the time of surgery no gelfoam injection for at least 4 months prior to initial data collection able to give informed consent willing and able to return for 6 and 12 month data collection sessions able and willing to perform questionnaire (by mail) 18 months after surgery Exclusion criteria abnormal non-paralyzed fold other disorders affecting the larynx (voice box), such as multiple sclerosis, myasthenia gravis, spasmodic dysphonia, or essential voice tremor prior surgery to either vocal fold previous or planned irradiation of the voicebox
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal C Paniello, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
UC-Irvine Medical Center
City
Irvine
State/Province
California
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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Surgery for Vocal Cord Paralysis

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